Alt Enzyme Assay Kit
FDA 510(k) K821946 · Travenol Laboratories, S.A.
510(k) numberK821946
Submission
- Device name
- Alt Enzyme Assay Kit
- Applicant
- Travenol Laboratories, S.A.
Walker, MI, US - Received
- June 30, 1982
- Decision date
- July 20, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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Questions and answers
When was Alt Enzyme Assay Kit cleared by the FDA?
Alt Enzyme Assay Kit (K821946) received a 510(k) decision of Substantially Equivalent on July 20, 1982, 20 days after the submission was received.
What is the product code of K821946?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.